WO2012150941A1 - Appareil et procédé pour la pose d'une attache chirurgicale - Google Patents

Appareil et procédé pour la pose d'une attache chirurgicale Download PDF

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Publication number
WO2012150941A1
WO2012150941A1 PCT/US2011/035355 US2011035355W WO2012150941A1 WO 2012150941 A1 WO2012150941 A1 WO 2012150941A1 US 2011035355 W US2011035355 W US 2011035355W WO 2012150941 A1 WO2012150941 A1 WO 2012150941A1
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WO
WIPO (PCT)
Prior art keywords
surgical
fastener
insertion apparatus
surgical fastener
component
Prior art date
Application number
PCT/US2011/035355
Other languages
English (en)
Inventor
Hugh H. TROUT
Terry Dahl
Kenneth A. Spector
Howard M. Tanner
Frank Patterson
Original Assignee
Eva Corporation
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Eva Corporation filed Critical Eva Corporation
Priority to PCT/US2011/035355 priority Critical patent/WO2012150941A1/fr
Publication of WO2012150941A1 publication Critical patent/WO2012150941A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/954—Instruments specially adapted for placement or removal of stents or stent-grafts for placing stents or stent-grafts in a bifurcation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/89—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2002/065—Y-shaped blood vessels
    • A61F2002/067—Y-shaped blood vessels modular
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • A61F2002/075—Stent-grafts the stent being loosely attached to the graft material, e.g. by stitching

Definitions

  • the present invention relates generally to an apparatus and method for use in surgical repair, more particularly for inserting, positioning, and attaching endovascular surgical grafts using a surgical fastener.
  • An embodiment of the present invention also relates generally to surgical fasteners, and more
  • surgical fasteners for use in attaching tissue to tissue, surgical component to tissue, and surgical component to surgical component.
  • An aneurysm is a ballooning of the wall of an artery resulting from the weakening of the artery due to disease or other conditions. Left untreated, the aneurysm will frequently rupture, resulting in loss of blood through the rupture and death.
  • Aortic aneurysms are the most common form of arterial aneurysm and are life threatening.
  • the aorta is the main artery which supplies blood to the circulatory system.
  • the aorta arises from the left ventricle of the heart, passes upward and bends over behind the heart, and passes down through the thorax and abdomen.
  • the abdominal aorta supplies two side vessels to the kidneys, the renal arteries.
  • the abdominal aorta continues to about the level of the fourth lumbar vertebrae (or the navel), where it divides into the iliac arteries.
  • the iliac arteries supply blood to the lower extremities and perineal region.
  • an aortic aneurysm it is common for an aortic aneurysm to occur in that portion of the abdominal aorta between the renal arteries and the iliac arteries. This portion of the abdominal aorta is particularly susceptible to weakening, resulting in an aortic aneurysm. Such an aneurysm is often located near the iliac arteries. An aortic aneurysm larger than about 5 cm in diameter in this section of the aorta is ominous. Left untreated, the aneurysm may rupture, resulting in rapid, and usually fatal, hemorrhaging. Typically, a surgical procedure is not performed on
  • Aneurysms in the abdominal aorta are associated with a particularly high mortality rate; accordingly, current medical standards call for urgent operative repair. Abdominal surgery, however, results in substantial stress to the body. Although the mortality rate for an aortic aneurysm is extremely high, there is also considerable mortality and morbidity associated with open surgical intervention to repair an aortic aneurysm. This intervention involves penetrating the abdominal wall to the location of the aneurysm to reinforce or replace the diseased section of the abdominal wall (i.e., abdominal aorta). A prosthetic device, typically a synthetic tube graft, is used for this purpose. The graft serves to exclude the aneurysm from the circulatory system, thus relieving pressure and stress on the weakened section of the aorta at the aneurysm.
  • a prosthetic device typically a synthetic tube graft
  • Embodiments of the present invention are directed to an apparatus, system, and method for inserting, positioning, attaching, and cutting endografts endovascularly, and to position and insert a surgical fastener at the surgical site.
  • An embodiment of the present invention is an insertion apparatus for deploying a surgical component to a site in a vessel comprising attachment means for attaching the surgical component to the insertion apparatus, wherein the attachment means is releasably connected to the surgical component and release means for releasing the attachment means from the surgical component, wherein the release means is in communication with the attachment means.
  • the insertion apparatus may comprise fastening means for fastening the surgical component to the vessel, and a graft.
  • the release means supplies an electric current and/or heat to the attachment means.
  • the attachment means may comprise at least one attachment wire and a support wire, and or an attachment hoop, at least one attachment wire, and a support wire.
  • the insertion apparatus may comprise a short sheath, and the short sheath may comprise a flare.
  • An embodiment of the present invention is an insertion apparatus for deploying a surgical component to a site in a vessel comprising at least one attachment wire with a first end and a second end, a support wire, wherein the first end of the at least one attachment wire is releaseably connected to the surgical component and the second end is connected to the support wire, and wherein the attachment wire and support wire positions the surgical component at a site in the vessel.
  • the insertion apparatus may further comprise a fastener delivery catheter.
  • the insertion apparatus may further comprise an introducer sheath.
  • the introducer sheath may comprise a homostatic valve and a dilator.
  • An embodiment of the present invention is an insertion apparatus for deploying a surgical component to a site in a vessel comprising an attachment hoop releasably connected to the surgical component, at least one attachment wire with a first end and a second end, a support wire, wherein the first end of the at least one attachment wire is connected to the attachment hoop and the second end of the at least one attachment wire is connected to the support wire, and wherein the insertion apparatus positions the surgical component in the vessel.
  • An embodiment of the present invention is an insertion system for deploying a surgical component to a site in a vessel comprising a surgical component, an insertion apparatus, attachment means for attaching the surgical component to the insertion apparatus, wherein the attachment means is releasably connected to the surgical component, and release means for releasing the attachment means from the surgical component, wherein the release means is in communication with the attachment means.
  • the system may also comprise a fastening means for fastening the surgical component to the vessel.
  • An embodiment of the present invention is a method for positioning a surgical component to a site in a vessel comprising the steps of, introducing an insertion apparatus proximal to the site in the vessel, activating the insertion apparatus, and withdrawing the insertion apparatus.
  • the method may further comprise the step of inserting an introducer catheter to the site in the vessel prior to introducing the insertion apparatus to the site in the vessel.
  • An embodiment of the present invention is a method for positioning a surgical component with an insertion apparatus to a site in a vessel comprising the steps of: introducing the insertion apparatus proximal to the site in the vessel; fastening the surgical component to the vessel; activating the insertion apparatus; and withdrawing the insertion apparatus.
  • An embodiment of the present invention is a catheter handle capable of controlling the insertion apparatus and/or the fastener apparatus and deploying surgical fasteners at the surgical site.
  • the present invention is directed to a surgical fastener for use during a surgical procedure for securing a first component to a second component.
  • the surgical fastener secures a first component to a second component under a force.
  • the surgical fastener has a first stressed configuration where the fastener is coupled to a restraining device that can be used to insert the surgical fastener into both components. After insertion, the restraining device can be removed resulting in a second unstressed configuration in which the surgical fastener has a substantially spiral shape on the outer side of both components.
  • the surgical fastener is spring biased towards the middle thereby securing the two components together.
  • the surgical fastener also includes a rib that extends along the longitudinal axis of the surgical fastener. The rib may facilitate more reliable insertion and more consistent advancement.
  • the surgical fastener may have a first configuration for inserting the surgical fastener through the second component and the first component, and a second
  • surgical fastener further comprises of at least one ring that is created by having a finger connect to the rib that runs along the longitudinal axis of the surgical fastener.
  • the ring assembly may further include using different ring dimensions and spring characteristics.
  • the rings can help facilitate a more effective surgical fastener. For example, in one embodiment, to reduce the chance of substantive bleeding, the rings are cut in a manner that results in closure of the rings when the surgical fastener assumes its second or spiraled configuration.
  • the surgical fastener instead of the surgical fastener being constructed from wire, it may now be laser cut from tubing; for example, laser cut Nitinol or cut by any suitable method.
  • Embodiments of the present invention are directed to a system, method and apparatus for inserting, positioning, attaching, and cutting endografts and surgical fasteners endovascularly.
  • An embodiment of the present invention is an insertion apparatus for deploying a surgical component to a site in a vessel comprising attachment means for attaching the surgical component to the insertion apparatus, wherein the attachment means is releasably connected to the surgical component and release means for releasing the attachment means from the surgical component, wherein the release means is in communication with the attachment means.
  • the insertion apparatus may comprise fastening means for fastening the surgical component to the vessel, and a graft.
  • the release means supplies an electric current and/or heat to the attachment means.
  • the attachment means may comprise at least one attachment wire and a support wire, and or an attachment hoop, at least one attachment wire, and a support wire.
  • the insertion apparatus may comprise a short sheath, and the short sheath may comprise a flare.
  • An embodiment of the present invention is an insertion apparatus for deploying a surgical component to a site in a vessel comprising at least one attachment wire with a first end and a second end, a support wire, wherein the first end of the at least one attachment wire is releaseably connected to the surgical component and the second end is connected to the support wire, and wherein the attachment wire and support wire positions the surgical component at a site in the vessel.
  • the insertion apparatus may further comprise a fastener delivery catheter.
  • the insertion apparatus may further comprise an introducer sheath.
  • the introducer sheath may comprise a homostatic valve and a dilator.
  • An embodiment of the present invention is an insertion apparatus for deploying a surgical component to a site in a vessel comprising an attachment hoop releasably connected to the surgical component, at least one attachment wire with a first end and a second end, a support wire, wherein the first end of the at least one attachment wire is connected to the attachment hoop and the second end of the at least one attachment wire is connected to the support wire, and wherein the insertion apparatus positions the surgical component in the vessel.
  • An embodiment of the present invention is an insertion system for deploying a surgical component to a site in a vessel comprising a surgical component, an insertion apparatus, attachment means for attaching the surgical component to the insertion apparatus, wherein the attachment means is releasably connected to the surgical component, and release means for releasing the attachment means from the surgical component, wherein the release means is in communication with the attachment means.
  • the system may also comprise a fastening means for fastening the surgical component to the vessel.
  • An embodiment of the present invention is a method for positioning a surgical component to a site in a vessel comprising the steps of, introducing an insertion apparatus proximal to the site in the vessel, activating the insertion apparatus, and withdrawing the insertion apparatus.
  • the method may further comprise the step of inserting an introducer catheter to the site in the vessel prior to introducing the insertion apparatus to the site in the vessel.
  • An embodiment of the present invention is a method for positioning a surgical component with an insertion apparatus to a site in a vessel comprising the steps of: introducing the insertion apparatus proximal to the site in the vessel; fastening the surgical component to the vessel; activating the insertion apparatus; and withdrawing the insertion apparatus.
  • An embodiment of the present invention is a catheter handle capable of controlling the insertion apparatus and/or the fastener apparatus and deploying surgical fasteners at the surgical site.
  • Figures 1 - 150 are views of an apparatus and method for inserting, positioning, attaching, and cutting an endograft, and for positioning and delivering a surgical fastener.
  • Figure 151 is a schematic view of a prior art surgical fastener.
  • Figure 152 is a schematic view of a surgical fastener according to an embodiment of the present invention in a relaxed coiled configuration.
  • Figure 153 is a schematic view of a surgical fastener according to an embodiment of the present invention in a stressed straight configuration.
  • Figure 154 is a schematic view of a surgical fastener according to an embodiment of the present invention attaching a surgical component to tissue.
  • Figure 155 is a schematic view of the rings of the surgical fastener according to an embodiment of the present invention.
  • Figure 156 is a schematic view of the rings of the surgical fastener according to an embodiment of the present invention.
  • Figure 157 is a schematic view of the rings of the surgical fastener according to an embodiment of the present invention.
  • Figure 158 is a schematic view of the rings of the surgical fastener according to an embodiment of the present invention
  • Figure 159 is a schematic view of a partially coiled surgical fastener according to an embodiment of the present invention.
  • Figure 160 is a schematic view of an occlusive device according to an embodiment of the present invention.
  • Figure 161 is a schematic view of an occlusive device according to an embodiment of the present invention.
  • Figure 162 is a schematic view of an occlusive device according to an embodiment of the present invention.
  • Figure 163 is a schematic view of an occlusive device according to an embodiment of the present invention.
  • the intra-abdominal arterial anatomy of a patient with an abdominal aortic aneurysm may consist of a suprarenal aorta 1 , renal arteries 2, a portion of infrarenal aorta that is not dilated 3 that makes up a part of the aortic neck 4, the aneurysm itself which is a dilated portion of the aorta 5, and the common iliac arteries 6, which creates the bifurcation 7 of the aorta at the level of the umbilicus.
  • Endovascular treatment of an abdominal aortic aneurysm may be achieved by inserting an endograft through a femoral or iliac artery and using this endograft to bypass the dilated aneurismal aorta.
  • This endograft can be fully supported meaning that a endoskeleton or an exoskeleton made of somewhat rigid struts from metal or plastic support the entire endograft. If the endograft has an exoskeleton or an endoskeleton over or within just a portion of the endograft this endograft can be said to be partially supported.
  • the minimally supported endograft 8 comprises an unsupported graft quite similar to the one used in the open operation for repair of an abdominal aortic aneurysm.
  • a short exoskeleton or endoskeleton stented portion 11 made of a flexible material such as Nitinol with shape memory characteristics (this can be any semi rigid material that can be deformed by a constraining mechanism and that will revert to its original shape once the constraint is removed).
  • Stented portion 11 may be from about 0.5-4 cm in height, or preferably between 1 -2 cm in height. Aside from the portion of the tube graft 10 that has the short exoskeleton or endoskeleton known as the stented portion 11 the remainder of the tube graft and the two limbs of the bifurcation endograft will be unsupported.
  • Figure 3 depicts the minimally supported endograft 8 inserted into position with the stented portion 11 of the endograft within the non-dilated aortic neck 4 and the two bifurcation limbs 12 within the iliac arteries 6.
  • Figure 4 depicts the minimally supported endograft 8 in position and the two limbs 12 positioned within the common iliac arteries 6.
  • Commercially available stents 13, either bare or covered, may be placed within the portion of the graft limbs 12 that is within the common iliac arteries 6.
  • the graft limbs 12 have been transected at end 14 proximal to the internal iliac arteries 15.
  • connection between the graft holder and the endograft could be disconnected by an electrical current, heat, a specialized light or by applying a mechanical force to the junction.
  • Many of these approaches are disclosed in Patent Application Nos. 10/424,775; 1 1 /366,604; 10/389,972; and U.S. Patent Nos. 6,409,757; 6,855,159; 6,648,912; 6,607,555; 6,706,047; 105,012; and
  • a delivery catheter 20 may be used to deliver surgical fasteners 26 to the surgical site in order to attach the graft 8 to the aortic wall 15.
  • the tip 21 of the delivery catheter 20 is near the top of the stent- graft 8.
  • Fig 6 depicts the inner sheath 22 advanced out the outer sheath 23 until the inner sheath 22 meets the stent-graft 8.
  • the back portion 24 of the delivery catheter 20 is pushed backward toward the portion of the aortic wall 15 opposite where the delivery catheter tip 21 has engaged the stent-graft 8.
  • the laser is activated and the optical fiber 25 and overlying surgical fastener 26 (but not the inner sheath) are advanced a fixed distance through the aortic wall 15 (Fig 8).
  • the laser is turned off and the optical fiber 25 is withdrawn with the surgical fastener 26 partially deployed (Fig 9).
  • the surgical fastener 26 is then fully deployed as the optical fiber 25 and inner sheath 22 are withdrawn inside the outer sheath 23 (Fig 10).
  • the surgical fastener 26 is left attaching the stent-graft 8 to the aortic wall 15. See also U.S. Patent Nos. 6,607,555 and 7,101 ,366, the disclosures of which are incorporated by reference in their entirety.
  • a guidewire 30 is inserted through the iliac artery 6 past the dilated aorta 5.
  • Fig. 12 shows introducer sheath 31 containing minimally supported graft 8 inserted over guidewire 30.
  • Graft holder 32 is inserted to a position in the suprarenal aorta wherein the entire graft 8 is positioned above the aortic bifurcation 7.
  • Fig. 13 shows introducer sheath 31 withdrawn to a level of the external iliac 6. Distal graft limbs 33 are free.
  • Fig. 12 shows introducer sheath 31 containing minimally supported graft 8 inserted over guidewire 30.
  • Graft holder 32 is inserted to a position in the suprarenal aorta wherein the entire graft 8 is positioned above the aortic bifurcation 7.
  • Fig. 13 shows introducer sheath 31 withdrawn to a level of the external iliac 6. Distal graft limbs 33 are free.
  • snare 34 is attached to guidewire 30.
  • snare 34 is pulled by guidewire 30.
  • Right limb sutures 36 remain in the right iliac artery 6.
  • left graft limb sutures 35 are passed into the left iliac artery 6 as shown in Fig. 16.
  • distal graft limbs 33 are pulled into the common iliac arteries 6.
  • Top portion 9 of minimally supported endograft 8 is now located in the infrarenal aortic neck. As shown in Fig.
  • a top portion 9 of minimally supported graft 8 is expanded within aortic neck 4.
  • guidewire 30 is inserted into the left limb 35 of graft 8 to a position above renal arteries 2.
  • sheath 31 is inserted over guidewire 30 into the left limb 35 of graft 8.
  • guidewire 30 and dilator 37 is removed from left introducer sheath 31 leaving introducer sheath 31 in tube portion 10 of graft 8.
  • surgical fastener catheter 16 is inserted into left introducer sheath 35.
  • surgical fasteners 26 are inserted circumferentially through top portion 9 of graft 8 into aortic wall 15.
  • the fastener delivery catheter 20 is removed, and if needed more surgical fasteners 26 may be inserted after the endograft holder 18 is removed.
  • Figure 24A depicts the distal end 41 of a Malecot type catheter graft holder 40 with four lumens 42 within the catheter with one in each of the
  • graft/stent positioning arms 43 As shown in Figure 24B, a small portion of the outer wall 44 of the graft/stent positioning arm 43 has been removed to expose the stent attachment wire 45 that is inserted into each of the four lumens 42.
  • Figure 24C shows the detail of the stent attachment of the endograft 8 to the Malecot type catheter 40 in that the wire 45 is passed up the catheter, then through a loop 46 in the stent 8, and then into the remainder of the distal catheter lumen.
  • the movable core wire 47 B Fig 24E below
  • the top of the endograft 8 will be partially collapsed and when the movable core wire 47 is partially withdrawn away from C distal end 41 (Fig 24F), the partially stented endograft 8 will be fully expanded.
  • Figure 24D shows an endograft 8 with a stent within it that is, in turn, attached to the Malecot type catheter 40 by the four stent attachment wires 45.
  • the four attachment wires 45 can be removed from the Malecot type catheter 40. This will allow reliable detachment of the Malecot type catheter 40 from the minimally stented endograft 8.
  • FIG. 25 As shown in Fig. 25, wires 45 removed Malecot pipe catheter 40 and the now released endograft holder 18 is contracted, as can be seen in Fig. 24F. As shown in Fig. 26 endograft holder 40 is removed and left introducer sheath 31 is retracted. As shown in Fig. 27, guidewires 30 may be inserted into both right and left limbs 33 of graft 8. If desired, stent 13 may be inserted over guidewire 30 in right limb 33 and positioned in the common iliac artery 6 within the graft limb 33. As shown in Fig. 29, the right limb stent 13 is unsheathed and expanded into right limb 33. As shown in Fig.
  • the left limb stent 13 may be inserted in a similar manner.
  • a snare type graft cutter 38 may be inserted over right graft limb 33 and positioned distal to the previously placed stent 13 and the excessed right limb graft 33 may be transected.
  • Left limb of graft 33 may be transected in a similar manner.
  • graft limbs 33 are transected to appropriate length and the excess is removed. Sheaths 31 are removed and the femoral arteries are repaired.
  • One embodiment of the present invention is a catheter within a catheter so that when the inner catheter 22 is advanced and the outer catheter 23 has been pressed against the contralateral wall 15 such that there is now a force of the inner catheter 22 compressing the endograft 8 against the aortic wall 15, as shown in Figures 5-10.
  • the following example provides the step-by-step instructions to assemble and test catheter handle 50, as shown in Fig. 35, according to an embodiment of the present invention.
  • the description is divided into sections specific to subassembly fabrication and contains illustrations and text to highlight the assembly procedure.
  • the instructions are written around a single unit but can be adapted by the user to accommodate batch production where appropriate. Detailed instruction for the check is provided and disposition for non-conforming product is defined.
  • An embodiment of the catheter handle may be comprised of the following components. Section numbers refer to the following sections describing the assembly of the catheter handle.
  • Step 1 Fig. 36.1 Apply four (4) evenly spaced droplets of #4061 Loctite Adhesive to the joint interface of Front RH Handle, PN VC02641 and Rear RH Handle, PN VC02642. Align joint interface and press and hold parts together for a minimum of 30 seconds for a complete bond. Set aside for additional assembly. Repeat for Front, LH Handle, PN VC02647 and Rear LH Handle, PN VC02648. PN VC02641 plus VC02642 becomes PN 1 192-P-0083. PN VC02647 plus VC02648 becomes PN 1 192-P-0084
  • Step 2 Fig. 36.2
  • the two inner handle halves fabricated in Step 1 will be formed into a "clam shell” during the handle assembly process.
  • fourteen (14) .031 " D x .188" L Dowel Pins are pressed into holes along the edge of PN 1 192-P-0083. Press the Pins until they bottom- out in their holes.
  • Step 3 Fig. 36.3 Heat set a 0-80 Threaded Insert in the hole located in the rear half of each of the Handle halves. It is important that once set, the Insert is flush with the surface of the Handle. If not set to the proper depth it may interfere with control hardware installed later in the assembly process. If necessary, re-set to make flush.
  • Step 1 Fig. 37.1 Apply a droplet of #4061 Loctite Adhesive to the outside of the small diameter of a Inner Catheter Tip, PN VC01688, and press into the flex end of a Dual Durometer - Flex Tube, PN VC01 171 , until the large diameter of the Tip contacts the Tube. Hold in place for a minimum of 10 seconds to eliminate possibility of movement. The hole in the Tip cannot be occluded by dried
  • Adhesive Inspect with 10X magnification. Clean hole with a small diameter pin if necessary.
  • Step 2 Fig. 37.2 Relative orientation between the two parts assembled here is very important. Keep the orientation of the Dual Durometer - Flex Tube the same as shown in Step 1 . Orient a Coupler, PN VC02656 as illustrated above. It is also important that the small diameter end of the Flex Tube passes easily into the small bore inside the block. Test the fit between the two parts before proceeding. Apply a droplet of #4061 Loctite Adhesive to the large diameter of the non-flex end of the Tube and press into the Coupler. Hold in place for a minimum of 10 seconds to eliminate possibility of movement. Visualize the orientation between the Tube and the Coupler. The cutouts in the flex end of the Tube must be on the same axis as the two holes in the Coupler. Reject if orientation is not correct.
  • Step 3 Insert a Lead-in Bushing, PN VC02661 , into a Hemostasis Port, PN 4F1 . Apply a droplet of Loctite Adhesive #4061 to the interface between the Bushing and the Port.
  • Step 4 Fig. 37.4 Relative orientation between the two parts assembled here is very important. Apply a droplet of Loctite Adhesive #4061 to the outside of the small diameter on the Port, and press Port into Coupler as illustrated above. Hold in place for a minimum of 10 seconds to eliminate the possibility of movement.
  • Step 5 Insert a 0.042 gauge pin into the opening in the Hemostasis Port and pass it through the Port, through the Lead-in Bushing and into the Inner Tube.
  • the Pin must pass smoothly without snagging any edges. Reject assembly if the transition between parts is not smooth. Remove Pin after test. Note: There may be some normal and acceptable resistance as the pin passes through the rubber seal in the Port.
  • Step 6 Fig. 37.6 Press a 0.062" D x 1 .875" L Dowel Pin into the non-threaded hole in Coupler. Press the Pin until it bottoms-out in the hole.
  • Step 7 Fig. 37.7 Press an identical Dowel Pin into the hole on the other side of the Coupler. Press the Pin until it bottoms-out in the hole.
  • Step 8 Fig. 37.8 Position the hole in a LH Drive Pin Bracket (short), PN
  • Step 9 Fig. 37.9 Turn the Coupler over and attach a RH Drive Pin Bracket (long), PN VC02663 in the same manner as Step 8 using a 2-56 x
  • Step 10 Fig. 37.10 Attach a Rack Control 2, PN VC02664 to the RH Drive Pin Bracket (long) with two (2) 2-56 x .188" SHCS backed-up by .250" x .094" x .025" Flat Washers. Snug with a hex wrench. Adjustment to the their relative position will be made later.
  • Step 1 1 Fig. 37.1 1
  • the dimension from where the pull wire enters the Outer Catheter, PN VC01 175-04-2, and the proximal end of the Catheter must be in a length range of 1 .41 " to 1 .51 ".
  • trim the proximal end of the Catheter sheath to achieve the required length.
  • An inadequate or incomplete cut may result in an unacceptable condition where the PTFE lining of the Catheter delaminates from the inner wall of the outer sheath (see photo). Re-trim (if length specification can be maintained) or reject the Outer Catheter if delamination occurs.
  • Step 12 Fig. 37.12 Slide a Catheter Clamp, PN VC02649, over the proximal end of the Outer Catheter and position it just ahead of where the pull wire enters (exits) the Catheter.
  • Step 14 Fig. 37.14 Slide a Pull Wire Clamp, PN VC02651 , over the proximal end of the Outer Catheter and position it just behind the Catheter Clamp.
  • Step 15 Fig. 37.15 Set the gap between the Catheter Clamp and the Pull Wire Clamp to 0.03". Remove any slack from wire. Using a hex wrench, secure the pull wire to the Clamp using a (1 ) 2-56 x .188" SHCS backed-up by a (1 ) .250" x .094" x .025" Flat Washer. Pinch the pull wire between the Clamp and the Flat Washer as the Screw is tightened.
  • Step 16 Fig. 37.16 Relative orientation between the parts assembled here is very important. Press a Hemostasis Valve, PN R1 c-1 , onto the proximal end of the Outer Catheter. Set the distance from the medial notch in the Outer Catheter Clamp to the reduced diameter in the Port to 1 .598". Confirm the relative orientation of the parts as illustrated above. Apply a droplet of #4061 Adhesive to the joint interface between the Catheter and Port and hold in place for a minimum of 10 seconds to eliminate the possibility of movement. [0041] Step 17, Fig.
  • Step 1 Fig. 38.1 . Locate the three (3) 2-56 threaded thru holes on the back-right of a Control 4 Rack, PN VC02667.
  • the inset illustration provides a guide to their location(s) using the raised feature on the Rack as a point of reference.
  • Step 2 Fig. 38.2. Position a Control 4 Drive Pin Adaptor, PN VC02670, on the back of the Rack so that the thru holes on the Adaptor line up with the threaded holes on the Rack.
  • Step 3 Fig. 38.3. Align the two parts by inserting a 0.070" gauge pin through the holes as shown.
  • Step 4 Fig. 38.4. Secure the Adaptor to the Rack with three (3) 2- 56 x .125 SHCS. Remove the gauge pin.
  • Step 5 Fig. 38.5 Attach a Fiber Optic Adjustment Housing, PN VC02669, to the front-right of the Rack with four (4) 0-80 x 0.188 SHCS.
  • Step 6 Fig. 38.6 Apply a droplet of Loctite Adhesive #4061 to the flat on the end of a Fiber Optic Adjustment Screw, PN VC02675.
  • Step 7 Fig. 38.7 Press a Fiber Optic Adjustment Boss, PN VC02676, onto the Adjustment Screw until completely seated and hold for a minimum of 10 seconds for adhesive to set. Set aside until Step 9.
  • Step 8 Fig. 38.8 Position a Fiber Optic Adjustment Nut, PN VC02671 , into the window in the Adjustment Housing as shown.
  • Step 9 Insert the Fiber Optic Adjustment Screw assembled in Step 7 into the bore in the Housing. Thread the Nut onto the Screw by turning in the direction noted. Be careful not to damage the Nut by cross- threading. The position of the Screw will be adjusted later.
  • Step 10 Fig. 38.10 Fix the position of the Screw and Nut in the Housing by pressing a 0.078" x 0.375" Dowel Pin in the thru hole in the Housing.
  • Step 1 1 Fig. 38.1 1 Press a Fiber Optic Strain Relief, PN XXX onto the end of the Screw assembly. Leave a small amount of clearance between the Strain relief and the Housing to prevent rotational interference.
  • Step 12 Fig. 38.12 Press a Rack Tooth, PN VC02668, into fifteen (15) positions along the front of the Rack. Note the direction of the Tooth relative to the Fiber Optic Adjustment Housing.
  • Step 13 Fig. 38.13 Carefully feed a Funnel Tube, PN VC02677, through the hole in a Funnel Bracket, VC02678 as shown.
  • the Tube must remain straight. Do not bend or kink.
  • Step 14 Fig. 38.14 Feed the end of the Tube in the hole in the Fiber Optic Adjustment Housing. Align the holes in the Funnel Bracket over the corresponding holes in the front of the Rack and attach with two (2) 0-80 x 0.125" SHCS.
  • Step 15 Fig. 38.15
  • the length of Funnel Tube exposed beyond the Funnel Bracket is very important. Set length to 0.770 + .020 prior to applying adhesive. Apply a droplet of Loctite Epoxy, M-121 HP to the joint interface between the Funnel Tube and the Funnel Bracket. Allow adhesive to dry 15 minutes prior to proceeding with assembly.
  • Step 16 Fig. 38.16 Locate the two (2) 2-56 threaded thru holes on the back-right of a Control 3 Rack, PN VC02681 .
  • the inset illustration provides a guide to the holes location using the raised feature on the Rack as a point of reference.
  • Step 17, Fig. 38.17 Position a Control 3 Drive Pin Adaptor, PN VC02682, on the back of the Rack so that the thru holes on the Adaptor line up with the threaded holes on the Rack.
  • Step 18, Fig. 38.18 Align the two parts by inserting a 0.070" gauge pin through the holes as shown.
  • Step 19 Fig. 38.19 Secure the Adaptor to the Rack with two (2) 2- 56 x .125 SHCS. Remove the gauge pin.
  • Step 20 Fig. 38.20 Press a Rack Tooth, PN VC02668, into fifteen (15) positions along the front of the Rack. Note the direction of the Tooth relative to the back-stop on the Rack.
  • Step 1 Fig. 39.1
  • the overall length of the Pusher Assembly is very important. Set length to 20.95 + 0.02 (from back of Pusher to distal end of Tube) prior to applying adhesive. Press one end of a Pusher Tube, PN VC02684, into the hole in the knife-edge of a Pusher, PN VC02683 and apply a droplet of Loctite Epoxy, M-121 HP to the joint. Allow to dry for a minimum of 10 minutes before further handling.
  • Step 1 Fig. 40.1 Press four (4) Control Sleeve 1 Drive Pins, PN VC02688 into the thru holes in a Control Sleeve 1 , PN VC02687.
  • the Pins must be flush with the inner diameter of the Sleeve. Reset if necessary.
  • Step 2 Fig. 40.2 Press four (4) Control Sleeve 2 Drive Pins, PN VC02701 into the thru holes in a Control Sleeve 2, PN VC02700.
  • the Pins must be flush with the inner diameter of the Sleeve. Reset if necessary.
  • Step 3 Fig. 40.3 Press two (2) Control Sleeve 3 Drive Pins, PN VC02707 into the thru holes in a Control Sleeve 3, PN VC02706.
  • the Pins must be flush with the inner diameter of the Sleeve. Reset if necessary.
  • Step 4 Press two (2) Control Sleeve 4 Drive Pins, PN VC02722 into the thru holes in a Control Sleeve 4, PN VC02721 .
  • the Pins must be flush with the inner diameter of the Sleeve. Reset if necessary.
  • Step 1 Fig. 41 .1 Position a Detent Spring, PN VC02717, inside an Interlock Release Ring, PN VC02716, as shown.
  • the Spring will grip the molded features in the Ring.
  • Step 2 Fig. 41 .2 Apply two (2) droplets of UV Cure Adhesive, #331 1 , in the locations shown.
  • Step 3 Fig. 41 .3 Position an End Plate, PN VC02718, against the adhesive and over the pins and lug of the Ring. Hold under UV light until completely cured (see Adhesive manufacturer's recommendations).
  • Step 1 Fig. 42.1 Position the assembly completed in Section II in the RH Handle shell assembled in Sec. I.
  • Step 2 Fig. 42.2A and 42.2B Position the Control 4 Rack Assembly (Section III) between the two Drive Pin Brackets as shown.
  • Step 3 Fig. 42.3A and 42.3B Position the Control 3 Rack Assembly (Section III) between the two Drive Pin Brackets and above Control 4 Rack Assembly as shown.
  • the Assembly will nest in the molded features in the RH Handle shell. The leading edges of both Rack Assemblies will be in alignment.
  • the next assembly step provides instruction for the installation of the LH Handle shell. This will close the unit and obscure the Internal Drive Mechanism from visual inspection. Before proceeding, re-check the components for proper placement and alignment.
  • Step 4 Fig. 42.4 Align the LH Handle shell over the pins in the RH shell and close the Handle. Care should be taken to make sure that all pins are in alignment and that the Hemostasis Ports do not interfere with complete closure. Temporary bands should be placed at the locations noted in the next assembly step to keep the unit closed during installation of the Controls.
  • Step 5 Fig. 42.5 Place temporary bands around the Handle Assembly at or near the locations noted. They will hold the halves of the Handle together as the Controls are installed and will be removed when instructed.
  • Step 1 Fig. 43.1 Install a Retainer Ring, PN VC02692, into the groove in Handle as shown.
  • Step 2 Fig. 43.2 Feed a Control Sleeve 1 (assembled in Section V), over Catheter, onto Handle and up against Retainer Ring. Chamfer on Sleeve must be away from Ring as shown.
  • Step 3 Fig. 43.3 Screw a Control 1 Drive Pin, PN VC02685, into place by orienting Sleeve as shown. Screw Pin into internal Rack until snug.
  • Step 4 Fig. 43.4 Turn the Handle over and screw the second Control 1 Drive Pin, PN VC02685 into place. Screw the Pin into the internal Rack until Snug.
  • Step 5 Fig. 43.5 Feed a Spacer, PN VC02689, over Catheter, onto Handle and up against the Control Sleeve.
  • Step 6 Fig. 43.6 In similar fashion to Step 5, feed a Control Ratchet 1 , PN VC02690, over Catheter, onto Handle and up against Spacer.
  • Step 7 Fig. 43.7 Fix the position of the Ratchet by installing a Retainer Ring, PN VC02692, in the groove as shown.
  • Step 8 Fig. 43.8 Feed a Washer, PN VC02691 , over the
  • Step 9 Fig. 43.9 Feed a 1 .375" x 1 .030" x 0.300" Wave Spring over Catheter, onto Handle and up against the Washer.
  • Step 10 Fig. 43.10 Fit the lower half of a Knob 1 , PN VC02694 to
  • Control 1 The lower Drive Pins in the Control Sleeve must fit in the molded-in track in the Knob half.
  • the Wave Spring may need to be compressed slightly to allow it to nest in the Knob. It is very important that the parts are not forced to fit. When properly aligned, the parts will come together with little or no effort. Avoid rotating the Sleeve from its installed position. This could alter the timing of the internal mechanism.
  • Step 1 1 , Fig. 43.1 1 Fit the upper half of a Knob 1 , PN VC02694 to
  • Control 1 The upper Drive Pins in the Control Sleeve must fit in the molded-in track in the Knob half. It is very important that the parts are not forced to fit. When properly aligned, the parts will come together with little or no effort. Avoid rotating the Sleeve from its installed position. This could alter the timing of the internal mechanism.
  • Step 12 Fig. 43.12 Fasten together the upper and lower halves of
  • Step 1 Fig. 45.1 Pass a 1 .375" x 1 .030" x 0.300" Wave Spring over the Fiber Optic Housing, onto the Handle and into position against the large diameter of the Handle (as shown above).
  • Step 2 Fig. 45.2 In a similar fashion, pass a Control 2 Washer, PN VC02697, a 1 .375" x 1 .030" x 0.300" Wave Spring onto the Handle and into position against the Wave Spring.
  • Step 3 Fig. 45.3 Install a Retainer Ring, PN VC02686, into the groove in Handle as shown.
  • Step 4 Fig. 45.4
  • Step 3 position a Control 2 Ratchet, PN VC02698, against the Ring installed in Step 3. Note the orientation of the teeth on the Ratchet. The keyway in the Ratchet must engage the key on the Handle.
  • Step 5 Fig. 45.5
  • Step 3 install a Retainer Ring, PN VC02686, in the groove next to the boss on the Ratchet.
  • Step 6 Fig. 45.6 Feed a Control 2 Spacer, PN VC02699, onto the Handle and position against the Retainer Ring as shown.
  • Step 7, Fig. 45.7 Feed a Control Sleeve 2 assembly (assembled in Sect. V) onto Handle and position against the Spacer.
  • the chamfer on the Sleeve must be towards the Spacer. Rotate the helical slot in the Sleeve so that the threaded hole in the Rack is visible as shown.
  • Step 8 Fig. 45.8 Screw into place a Control 2 Drive Pin, PN VC02696, keeping rotational orientation of Sleeve as shown. Screw the Pin into internal Rack until snug.
  • Step 9 Fig. 45.9 Turn the Handle over and locate the second threaded hole in the internal Rack. Ensure rotational orientation of Sleeve is as shown.
  • Step 10 Fig. 45.10 Screw the second Control 2 Drive Pin, PN VC02696 into place Thread the Pin into the internal Rack until Snug.
  • Step 1 1 Fig. 45.1 1 Fix the position of the Control Sleeve by installing a Retainer Ring, PN VC02686, in the groove as shown.
  • Step 12 Fig. 45.12 Fit the lower half of a Knob 2, PN VC02702, to Control 2.
  • the lower Drive Pins in the Control Sleeve must fit in the molded-in track in the Knob half. It is very important that the parts are not forced to fit.
  • the Wave Spring may need to be compressed slightly to allow it to nest in the Knob. When properly aligned, the parts will come together with little or no effort. Avoid rotating the Sleeve from its installed position. This could alter the timing of the internal mechanism.
  • Step 13 Fig. 45.13 Fit the upper half of a Knob 2, PN VC02702 to Control 2.
  • the upper Drive Pins in the Control Sleeve must fit in the molded-in track in the Knob half. It is very important that the parts are not forced to fit. When properly aligned, the parts will come together with little or no effort. Avoid rotating the Sleeve from its installed position. This could alter the timing of the internal mechanism.
  • Step 14 Fig. 45.14 Fasten together the upper and lower halves of Knob 2 with two (2) 2-56 x 0.250" SHCS and two (2) Cylindrical Nuts, PN
  • Step 1 Fig. 47.1 Pass a 1 .375" x 1 .030" x 0.300" Wave Spring over the Fiber Optic Housing, onto the Handle and into position as shown.
  • Step 2 Fig. 47.2 Pass a Control 3 Washer, PN VC02704,
  • Step 3 Fig. 47.3 Install a Retainer Ring, PN VC02686, into the groove in Handle as shown.
  • Step 4 Fig. 47.4 In similar fashion to Steps 1 and 2, position a Control 3 Ratchet, PN VC02705, against the Ring installed in Step 3. Note the orientation of the teeth on the Ratchet. The notch in the Ratchet must be UP.
  • Step 5 Fig. 47.5
  • Step 3 install a Retainer Ring, PN VC02686, in the groove behind the Ratchet.
  • Step 6 Fig. 47.6 Install a Retainer Ring, PN VC02686, in the groove shown.
  • Step 7 Fig. 47.7 Feed a Control Sleeve 3 assembly (assembled in Sect. V) onto Handle and position above the thru slot in the Handle.
  • the chamfer on the Sleeve must be towards the Retainer Ring.
  • Step 8 Fig. 47.8 Screw into place a Control 4 Drive Pin, PN VC02709, by orienting the Sleeve as shown. Screw Pin into the internal Rack until snug. Note: Handle half is transparent to show internal Rack detail.
  • Step 9 Fig. 47.9 Turn the Handle over and screw into place a Control 2 Rack Drive Pin, PN VC02708. Screw the Pin into the internal Rack until Snug. Note: The Handle half is transparent to show internal Rack detail.
  • Step 10 Fig. 47.10 Install a Pawl Spring, PN VC02712, into a Pawl, PN VC02713, by inserting the shorter of the two extensions into the small hole in the Pawl.
  • Step 1 1 Fig. 47.1 1 Position the Pawl and Spring into the cradle in a Control 3 Knob Bottom, PN VC0271 1 .
  • the long extension of the Spring fits into the small thru hole in the cradle. When installed properly, the Pawl will pivot freely in the cradle.
  • Step 12 Fig. 47.12 Fit the bottom of the Knob 3 assembly, to Control 3.
  • the lower Drive Pin in the Control Sleeve must fit in the molded-in track in the Knob half and two, the dog on the Pawl should rest on the first tooth of the Ratchet as illustrated.
  • the Wave Spring may need to be compressed slightly to allow it to nest in the Knob. It is very important that the parts are not forced to fit. When properly aligned, the parts will come together with little or no effort. Avoid rotating the Sleeve from its installed position. This could alter the timing of the internal mechanism.
  • Step 13 Fig. 47.13 Fit the upper half of Knob 3, PN VC02710 to Control 3.
  • the upper Drive Pin in the Control Sleeve must fit in the molded-in track in the Knob half. It is important that the parts are not forced to fit. When properly aligned, the parts will come together with little or no effort. Avoid rotating the Sleeve from its installed position. This could alter the timing of the internal mechanism.
  • Step 14 Fig. 47.14 Fasten together the upper and lower halves of Knob 3 with two (2) 2-56 x 0.250" SHCS and two (2) Cylindrical Nuts, PN
  • Step 1 Fig. 49.1 Identify the chamfer on either boss on an Interlock Bracket, PN VC02714, and using the chamfer as a lead-in, pass the Bracket over the Fiber Optic Housing, onto the Handle and into position adjacent to Control Knob 3 so that the hole in the boss (both sides) are in alignment with the brass inserts in the Handle.
  • Step 2 Fig. 49.2 Fasten the Bracket to the Handle with two (2) 0- 80 X 0.250" SHCS. Tighten until snug. Do not over-tighten.
  • Step 3 Fig. 49.3 Identify the lug on the Interlock Assembly (assembled in Section VI) and positioning the lug DOWN, pass the Interlock Assembly over the Fiber Optic Housing, onto the Handle and into position on the Bracket. Compress the Assembly slightly at the finger grips to allow the internal spring to pass over and into the notches in the Bracket. Full view is shown in Fig. 50. END OF SECTION XI
  • Step 1 Fig. 51 .1 Pass a 1 .375" x 1 .030" x 0.300" Wave Spring over the Fiber Optic Housing, onto the Handle and into position adjacent to the Interlock Bracket as shown.
  • Step 2 Fig. 51 .2 Pass a Washer, PN VC02720, over the Fiber Optic Housing, onto the Handle and into position adjacent to the Wave Spring as shown.
  • Step 3 Fig. 51 .3
  • Step 3 position a Control 4 Ratchet, PN VC02719, against the Washer installed in Step 2. Note the orientation of the teeth on the Ratchet. The notch in the Ratchet must be UP.
  • Step 4 Fig. 51 .4 Install a Retainer Ring, PN VC02692, into the groove in Handle as shown.
  • Step 5 Fig. 51 .5
  • Step 5 install a Retainer Ring, PN VC02692, in the groove shown.
  • Step 6 Fig. 51 .6 Feed Control Sleeve 4 assembly (assembled in Sect. V) onto Handle and position above the thru slot in the Handle.
  • the chamfer on the Sleeve must be towards the Retainer Ring.
  • Step 7 Fig. 51 .7 Screw into place a Control 4 Drive Pin, PN
  • Step 8 Fig. 51 .8 Rotate the Handle approximately 90o to locate the hole for the second Drive Pin.
  • Step 9 Fig. 51 .9 Screw into place a (1 ) Control 2 Rack Drive Pin, PN VC02708, by orienting Sleeve as shown. Screw Pin into internal Rack until snug.
  • Step 10 Fig. 51 .10 Install a Pawl Spring, PN VC02712, into a Pawl, PN VC02713, by inserting the shorter of the two extensions into the small hole in the Pawl.
  • Step 1 1 Fig. 51 .1 1 Position the Pawl and Spring into the cradle in a Control 4 Knob Bottom, PN VC02724.
  • the long extension of the Spring fits into the small thru hole in the cradle. When installed properly, the Pawl will pivot freely in the cradle.
  • Step 12 Fig. 51 .12 Fit the Bottom of Knob 4 assembly, to Control 4.
  • the lower Drive Pin in the Control Sleeve must fit in the molded-in track in the Knob half and two, the dog on the Pawl should rest on the first tooth of the Ratchet as illustrated.
  • the Wave Spring may need to be compressed slightly to allow it to nest in the Knob. It is very important that the parts are not forced to fit. When properly aligned, the parts will come together with little or no effort. Avoid rotating the Sleeve from its installed position. This could alter the timing of the internal mechanism.
  • Step 13 Fig. 51 .13 Fit the upper half of a Knob 4, PN VC02723 to Control 4.
  • the upper Drive Pin in the Control Sleeve must fit in the molded-in track in the Knob half. It is very important that the parts are not forced to fit. When properly aligned, the parts will come together with little or no effort. Avoid rotating the Sleeve from its installed position. This could alter the timing of the internal mechanism.
  • Step 14 Fig. 51 .14 Fasten together the upper and lower halves of Knob 4 with two (2) 2-56 x 0.250" SHCS and two (2) Cylindrical Nuts, PN
  • Step 15 Fig. 51 .15 Install the Cover, PN VC02725, onto the tail of the Handle over the Fiber Optic Strain Relief. Secure the Cover by pushing onto the Handle until the locating hole snaps onto the pin on the Handle. Full view is shown in Fig. 52.
  • Step 1 Fig. 53.1 Fit the lower half of a Grip, PN VC02703, to the Handle between Controls 2 and 3.
  • the Grip half will fit into molded-in features that will locate the Grip and keep it from rotating.
  • Step 2 Fig. 53.2 In similar fashion to Step 1 , fit the upper half of a Grip, PN VC02703 to the Handle.
  • Step 3 Fig. 53.3 Fasten together the upper and lower halves of the Grip with two (2) 2-56 x 0.250" SHCS and two (2) Cylindrical Nuts, PN
  • One embodiment of the present invention is a complete delivery system including the delivery catheter.
  • Figures 55 - 150 are additional views of the catheter handle and its component parts according to an embodiment of the present invention.
  • the handle, its component parts, and the assembly of the handle are discussed in the paragraphs provided above and previously shown in Figs. 35 - 54.
  • the first comprises various ways of expanding and constructing the stented portion within the tube portion of the endograft.
  • One approach is the Malecot concept whereby the stent can be constricted by advancement of a rigid rod against the tip of the Malecot and expanded by retraction of the rod.
  • Another possibility might be an umbrella type structure that can be screwed open and closed.
  • a second component to the insertion of a minimally supported endograft may be how the holder of the endograft is safely and reliably separated from the endograft once the endograft is sufficiently attached to the aortic wall. It is highly likely that the holder will be attached to the stented portion of the endograft. This connection between the holder and the endograft must be in some way severed so that the holder can be removed. This connection can be made with a substance that could reliably be disrupted by applying a current, heat, cold, vibration, a light source, or some other form of energy that is known to disrupt substances that are providing binding to two disparate (or similar) materials. While one embodiment is predicated on disrupting this connection by pulling out wires, a variety of suitable attachment mechanisms that allow reliable disruption may be used.
  • One embodiment permits one to transect the endograft limbs within the common iliac arteries.
  • One embodiment may comprise an insulated snare where the snare is an electrical filament that is insulated on the outside. Any other suitable methods other than heat that may also reliably and easily transect the limbs of an endograft within a flowing blood stream.
  • the catheter could be equipped with alternative means of transecting the endograft limb.
  • the endograft could be transected using any mechanical, electrical, or optical force, including but not limited to mechanical cutting, or any other suitable method that can be adapted for the catheter.
  • Figure 151 depicts a surgical fastener as described in U.S. Patent Nos. 5,997,556, 6,248,1 18, 6,520,974, and 7,699,858 herein incorporated in their entirety by reference.
  • Surgical fastener 50 may be composed of any suitable material, such as, but not limited to, shape memory metal alloy wire or plastic, such as, but not limited to Nitinol, or any other suitable material.
  • the material may include additional elements which affect the yield strength of the material or the temperature or other stimulus, including but not limited to electrical, magnetic, or aqueous at which particular pseudoelastic or shape transformation characteristics occur.
  • the transformation temperature or stimulus may be defined as the temperature or stimulus at which a shape memory or plastic alloy finishes transforming from martensite to austenite upon heating or stimulus.
  • the shape memory alloy preferably exhibits pseudoelastic (superelastic) behavior when deformed at a temperature slightly above its transformation temperature.
  • At least a portion of the shape memory alloy is converted from its austenitic phase to its martensitic phase when the wire is in its deformed configuration.
  • the material undergoes a martensitic to austenitic conversion and springs back to its original undeformed configuration.
  • a residual stress is present to maintain the tissue tightly together.
  • the surgical fastener 50 should not be stressed past its yield point in its deformed configuration to allow complete recovery of the wire to its undeformed
  • the shape memory alloy is preferably selected with a
  • transformation temperature suitable for use with a stopped heart condition where cold cardioplegia has been injected for temporary paralysis of the heart tissue e.g., temperatures as low as 8-10 degrees Celsius.
  • shape memory alloy may also be heat activated, or a combination of heat activation and pseudoelastic properties may be used, as is well known by those skilled in the art.
  • the surgical fastener 50 is distorted into a first configuration to allow it to be placed sequentially over or within a penetration apparatus, such as, but not limited to, an optical fiber, and inserted sequentially through a first component and a second component.
  • the first component or second component may be a tissue, surgical component, or any combination, such as, but not limited to, a prosthetic graft and vessel or aortic wall.
  • surgical fastener 50 includes, but not limited to, hernia repair, bowel anastomosis, dissection of an artery, etc.
  • Surgical fastener 50 may be of about 0.0254 mm to about 2.54 mm diameter, such as, but not limited to, about 0.508 to about 1 .524 mm diameter with a lumen of about 0.0254 mm to about 2.54 mm diameter, such as, but not limited to, about 0.127 to about 1 .27 mm diameter.
  • surgical fastener 50 is a tubular structure and may comprise a rib 80 that may reduce compression, facilitate more consistent advancement, and may be of varying width.
  • Rib 80 may be straight or helical, and may be integrated into, or form a wall of, surgical fastener 50, or may be disposed within the tubular structure or disposed on the exterior of surgical fastener 50.
  • Surgical fastener 50 may also comprise at least one ring 90 attached to rib 80. At least one rib 80 and/or at least one ring 90 may extend beyond the tubular structure to assist in anchoring of surgical fastener 50 in the first and/or second component.
  • At least one rib 80 and/or at least one ring 90 may contain a rough or serrated edge or edges to assist in anchoring of surgical fastener 50 in the first and/or second component.
  • Surgical fastener 50 may also comprise tip 100, which may be disposed on the leading or trailing end portion of surgical fastener 50.
  • surgical fastener 50 is shaped into a primary coil (that may be, but is not limited to, approximately between 0.0254 mm and 2.54 mm in diameter) that is, in turn, set into a secondary coil, by heat or any other suitable means (that may be, but is not limited to, approximately between 0.0254 mm and 2.54 mm in diameter).
  • a primary coil that may be, but is not limited to, approximately between 0.0254 mm and 2.54 mm in diameter
  • a secondary coil by heat or any other suitable means (that may be, but is not limited to, approximately between 0.0254 mm and 2.54 mm in diameter).
  • the surgical fastener 50 is deflected into a single coil and loaded onto or around a penetration apparatus, such as, but not limited to, an optical fiber; the penetration apparatus is positioned adjacent to a first component, such as, but not limited to, a prosthetic graft, a penetration means, such as, but not limited to, a Holmium laser is pulsed through the fiber allowing the laser energy to create a hole through the prosthetic graft and a second component, such as, but not limited to, an adjacent aorta as the fiber and overlying surgical fastener 50 are advanced; the optical fiber is then withdrawn and the fastener 50 then assumes its first coiled coil
  • Figure 154 depicts the coiled coil that has been inserted from within the aortic lumen through a prosthetic graft 54 and an adjacent vessel wall 55.
  • One of the primary coils has been left positioned within the vessel lumen, a portion of the coiled coil 60 traverses the prosthetic graft and vessel and the remainder of the coiled coil 70 (secondary coil) is positioned adjacent to the outside of the vessel in an area called the periadvential tissue. Once in position, tissue ingrowth into the interstices of the coils may provide further resistance to surgical fastener 50 dislodgment.
  • the primary coil contains only one coil so as to minimize the amount of fastener that is left inside the vessel.
  • the secondary coil can contain more coils because it is located outside of the vessel.
  • surgical fastener 50 may be comprised of a metal alloy, plastic or any other suitable material that may be set in a first configuration and distorted into a second configuration without losing its ability to resume its first configuration when a distorting force is removed.
  • Figure 153 shows a rib 80 with rings 90 attached.
  • the rib 80 can be of varying width and can be helically positioned, as shown, or it can be straight.
  • Figures 155-159 show views of various embodiments of rib 80 and attached rings 90.
  • Rings 90 can be cut in any configuration; specifically the width may vary, the space between ribs 80 may vary, and the bias at which ribs 80 are cut may vary.
  • the desired ring 90 configurations, as shown, may be broader near rib 80 and narrower at the portion opposite rib 80 to enhance closure of rings 90 when surgical fastener 50 is in its second, or relaxed coiled coil configuration.
  • the desired bias at which rings 90 are cut may facilitate the closure of rings 90, although there could be instances when the bias could be different in order to more readily achieve other goals such as facilitating resistance to distracting forces (hernia repair for instance).
  • Connection 110 of ring 90 to rib 80 may be of any suitable configuration and width.
  • Connection 110 of the embodiment depicted in Figure 154 has a "bow tie" shape and selected for its ability to facilitate ring 90 closure and to reduce rib 80 and ring 90 interface stress.
  • Figure 159 shows an embodiment of the present invention in a coiled configuration illustrating rib 80 and a plurality of rings 90 attached to rib 80 and compressed into a closed configuration 120.
  • this structure reduces the likelihood of bleeding through the interstices of rings 90.
  • the space between ribs 80 may be large, it may be desirable to dispose or attach a foam or sponge, or any other suitable material, in these spaces in order to allow movement of rings 90 when a penetration apparatus is bent or removed but also provide a barrier to bleeding through the spaces between rings 90.
  • Rings 90 can be cut at any width and/or any angle and the distance between rings 90 can vary as well. There can also be more than one rib 80.
  • Figure 160 shows the occlusive device 140.
  • occlusive device 140 is comprised of a single flap valve 190 with a double hinge 200 that may be laser cut at the same time rings 90 are cut as part of surgical fastener 50.
  • Occlusive device 140 may positioned at the leading edge of surgical fastener 50 but, regardless of its design, may also be located at the trailing edge or anywhere between the two ends of surgical fastener 50, or in a tip 100 attached to surgical fastener 50.
  • occlusive device 140 is positioned as if it were being held open by a penetration device, such as, but not limited to, an optical fiber passing through its lumen.
  • Occlusive device 140 may be composed of any suitable material, such as, but not limited to, shape memory metal alloy wire or plastic, such as, but not limited to Nitinol, or any other suitable material.
  • Figure 161 depicts the occlusive device 140 in its relaxed state once the penetration apparatus has been removed from the lumen of the tubing 150.
  • Figure 162 depicts tip 100 with a taper 170.
  • the occlusive device 140 consisting of a single flap valve 190 with a single hinge 180.
  • the taper 170 and occlusive device 140 can be each be manufactured separately and combined with the staple described above or, in the preferred iteration, the staple, taper tip and occlusive mechanism can be cut from the same piece of material.
  • Figure 163 shows an end view with the occlusive device 140 in its relaxed state occluding almost all of the lumen of surgical fastener 50. Only small spaces 160 may remain that could allow passage of blood through surgical fastener 50 lumen.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Pulmonology (AREA)
  • Surgical Instruments (AREA)

Abstract

La présente invention concerne un procédé et un appareil pour l'introduction, le positionnement, la fixation et la coupe d'endogreffes de façon endovasculaire. L'invention concerne un cathéter, un manche de cathéter et une attache chirurgicale ayant une première et une seconde extrémité pour fixer ensemble au moins deux surfaces. L'attache chirurgicale présente une première configuration dans laquelle l'attache est accouplée à un dispositif de retenue qui maintient l'attache et une seconde configuration dans laquelle l'attache est libérée dudit dispositif de retenue. La seconde configuration présente une forme sensiblement en spirale et est sollicitée par ressort le long d'un axe perpendiculaire aux surfaces qu'elle fixe. L'attache chirurgicale comprend également une nervure qui s'étend le long de l'axe longitudinal de l'attache.
PCT/US2011/035355 2011-05-05 2011-05-05 Appareil et procédé pour la pose d'une attache chirurgicale WO2012150941A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/US2011/035355 WO2012150941A1 (fr) 2011-05-05 2011-05-05 Appareil et procédé pour la pose d'une attache chirurgicale

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/US2011/035355 WO2012150941A1 (fr) 2011-05-05 2011-05-05 Appareil et procédé pour la pose d'une attache chirurgicale

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WO2012150941A1 true WO2012150941A1 (fr) 2012-11-08

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030208260A1 (en) * 1994-09-08 2003-11-06 Lilip Lau Procedures for introducing stents and stent-grafts
US20070299497A1 (en) * 1998-12-11 2007-12-27 Endologix, Inc. Implantable vascular graft
US20090138066A1 (en) * 1996-12-23 2009-05-28 Leopold Eric W Implant Deployment Apparatus
US7736299B2 (en) * 2002-11-15 2010-06-15 Paracor Medical, Inc. Introducer for a cardiac harness delivery

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030208260A1 (en) * 1994-09-08 2003-11-06 Lilip Lau Procedures for introducing stents and stent-grafts
US20090138066A1 (en) * 1996-12-23 2009-05-28 Leopold Eric W Implant Deployment Apparatus
US20070299497A1 (en) * 1998-12-11 2007-12-27 Endologix, Inc. Implantable vascular graft
US7736299B2 (en) * 2002-11-15 2010-06-15 Paracor Medical, Inc. Introducer for a cardiac harness delivery

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